Canal hearing devices and batteries for use with same

ABSTRACT

Hearing devices configured to fit within the bony portion of the ear canal and batteries that may be used with same.

BACKGROUND

1. Field

The present inventions relate generally to hearing devices and, forexample, hearing devices that are worn entirely in the bony region ofthe ear canal for extended periods without daily insertion and removal.

2. Description of the Related Art

The external acoustic meatus (ear canal) 10 is generally narrow andcontoured, as shown in the coronal view illustrated in FIG. 1. The adultear canal 10 is axially approximately 25 mm in length from the canalaperture 12 to the tympanic membrane or eardrum 14. The lateral part ofthe ear canal 10, i.e., the part away from the tympanic membrane, is thecartilaginous region 16. The cartilaginous region 16 is relatively softdue to the underlying cartilaginous tissue, and deforms and moves inresponse to the mandibular or jaw motions, which occur during talking,yawning, eating, etc. The medial part of the ear canal 10, i.e., thepart toward the tympanic membrane 14, is the bony region 18 (or “bonycanal”). The bony region 18, which is proximal to the tympanic membrane14, is rigid, roughly 15 mm long and represents approximately 60% of thecanal length. The skin in the bony region 18 is thin relative to theskin in the cartilaginous region and is typically more sensitive totouch or pressure. There is a characteristic bend, which occursapproximately at the bony-cartilaginous junction 20, that separatescartilaginous region 16 and from bony region 18, commonly referred to asthe second bend of the ear canal.

Debris 22 and hair 24 in the ear canal are primarily present in thecartilaginous region 16. Physiologic debris includes cerumen or earwax,sweat, decayed hair and skin, and sebaceous secretions produced by theglands underneath the skin in the cartilaginous region. Non-physiologicdebris is also present and may consist of environmental particles,including hygienic and cosmetic products that may have entered the earcanal. The bony portion of the ear canal does not contain hairfollicles, sebaceous, sweat, or cerumen glands. Canal debris isnaturally extruded to the outside of the ear by the process of lateralepithelial cell migration, offering a natural self-cleansing mechanismfor the ear.

The ear canal 10 terminates medially with the tympanic membrane 14.Lateral of and external to the ear canal is the concha cavity 26 and theauricle 28, which is cartilaginous. The junction between the conchacavity 26 and cartilaginous region 16 of the ear canal at the aperture12 is also defined by a characteristic bend 30, which is known as thefirst bend of the ear canal. Canal shape and dimensions can varysignificantly among individuals.

Extended wear hearing devices are configured to be worn continuously,from several weeks to several months, inside the ear canal. Such devicesmay be miniature in size in order to fit entirely within the ear canaland are configured such that the receiver (or “speaker”) fits deeply inthe ear canal in proximity to the tympanic membrane 14. To that end,receivers and microphones that are highly miniaturized, but sufficientlysized to produce acceptable sound quality, are available for use ishearing devices. The in-the-canal receivers are generally in the shapeof a rectangular prism, and have lengths in the range of 5-7 mm andgirths of 2-3 mm at the narrowest dimension. Receivers with smallerdimensions are possible to manufacture, but would have lower outputefficiencies and the usual challenges of micro-manufacture, especiallyin the coils of the electromagnetic transduction mechanism. Thereduction in output efficiency may be unacceptable, in the extended wearhearing device context, because it necessitates significant increases inpower consumption to produce the required amplification level for ahearing impaired individual. Examples of miniature hearing aid receiversinclude the FH and FK series receivers from Knowles Electronics and the2600 series from Sonion (Denmark). With respect to microphones, themicrophones employed in in-the-canal hearing devices are generally inthe shape of a rectangular prism or a cylinder, and range from 2.5-5.0mm in length and 1.3 to 2.6 mm in the narrowest dimension. Examples ofminiature microphones include the FG and TO series from KnowlesElectronics, the 6000 series from Sonion, and the 151 series fromTibbetts Industries. Other suitable microphones include siliconmicrophones (which are not yet widely used in hearing aids due to theirsuboptimal noise performance per unit area).

Recently introduced extended wear hearing devices are configured to belocated in both the cartilaginous region 16 and the bony region 18 ofthe ear canal 10. A design exists for an extended wear hearing deviceintended to rest entirely within the bony region 18 and is disclosed inU.S. Patent Pub. No. 2009/0074220 to Shennib (“Shennib”). There are anumber of advantages associated with the placement of a hearing deviceentirely within the ear canal bony region 18. For example, placementwithin the ear canal bony region 18 and entirely past thebony-cartilaginous junction 20 avoids the dynamic mechanics of thecartilagenous region 16, where mandibular motion, changes in theposition of the pina, such as during sleep, and other movements resultin significant ear canal motion that can lead to discomfort, abrasions,and/or migration of the hearing device. Another benefit of placementwithin the ear canal bony region 18 relates to the fact that sweat andcerumen are produced lateral to the bony-cartilaginous junction 20.Thus, placement within the bony region 18 reduces the likelihood ofhearing device contamination. Sound quality is improved because“occlusion,” which is caused by the reverberation of sound in thecartilaginous region 16, is eliminated. Sound quality is also improvedbecause the microphone is placed relatively close to the tympanicmembrane, taking advantage of the directionality and frequency shapingprovided by the outer parts of the ear, so that sound presented to thehearing device microphone more closely matches the sound that thepatient is accustomed to receiving at their tympanic membrane.

Although conventional hearing devices that are configured to be placedentirely within the bony region 18 are an advance in the art, thepresent inventors have determined that they are susceptible toimprovement. For example, the hearing device disclosed in Shennib has acore, which includes a power source, a microphone and a receiver thatare located within a housing, and also has a pair of acoustic seals thatengage the outer surface of the core housing and support the core withinthe ear. While Shennib teaches that a desirable length for such ahearing device (in the lateral-medial direction) is 12 mm or less, thepresent inventors have determined that there are other dimensional andacoustic issues which must be addressed, and that the configurations ofconventional hearing devices do not address these dimensional andacoustic issues in a manner that will allow the hearing devices to bothfit within the bony region in a significant portion (i.e., at least 75%)of the adult population and provide acceptable sound quality.

Other issues identified by the present inventors are associated with thebatteries that power in-the-canal hearing devices. For example, theconfiguration of conventional hearing device batteries preventsbatteries that have sufficient power capacity (measured in, for example,milliamp hours (mAh)) from being shaped in a manner that would enable anoverall hearing device configuration which allows the hearing device tofit within the ear canal bony region in a significant portion of theadult population.

Zinc-air batteries (and other metal-air batteries) are frequently usedin hearing devices because of their volumetric energy efficiency.Zinc-air batteries can be a challenge to design and manufacture becausethe cathode assembly must have access to oxygen (i.e., air) and theelectrolyte solution, commonly a very slippery sodium hydroxide solutionor potassium hydroxide solution, must be contained within the batterycan without leaking. The conventional method of containing theelectrolyte within the battery involves crimping the cathode assemblyaround an anode can with a sealing grommet between the two. Due to thechallenges associated with mass production, the most common crimpedbattery is the button cell, which includes short, cylindrical anode andcathode cans that can be stamped (or drawn) and crimped uniformly.However, as noted in U.S. Pat. No. 6,567,527 to Baker et al. (“Baker”),button cells are not sufficiently volumetrically efficient to providethe capacity for an extended wear deep-in-canal (DIC) hearing device.Baker discloses a zinc-air battery that has a bullet-shaped anode can,with an oval cross-section, formed from a stainless steel clad material(bi-clad copper-steel or tri-clad copper-steel-nickel). Steel is thestructural material, i.e., the material that provides the structuralsupport for the anode can, and the inner surface is oxygen free copper.Implicit in the use steel for the structural material is the fact thatthe anode can is formed by a stamping or drawing process. With respectto the crimping process that secures the cathode assembly and anode canto one another and creates the seal at the grommet, Baker discloses theformation of an internal retention ledge on the inner surface of theanode can that opposes the crimp force. The internal retention ledge isformed by welding or brazing a retention ring into a step on the innersurface of the anode can. The retention ledge supports a sealing grommetagainst which the cathode assembly and cathode base are crimped bybending the anode can around the cathode base. Alternately, Bakerteaches a retention ledge formed by collapsing a portion of the caninwardly with a bending (or “beading”) and crimping process.

Although the Baker anode cans are advantageous for a variety of reasons,the present inventors have determined that they are susceptible toimprovement. For example, the amount of crimp force that may be employedto join the anode can and the cathode assembly, and create the seal, islimited by the amount of force that the internal ledges can withstandwithout cracking or bending. The bullet-shaped Baker anode cans mustalso be supported from below during the crimping process and,accordingly, the crimp force must not exceed the buckling strength ofthe bullet-shaped can. Baker discloses a battery (FIG. 13 of Baker)where an indented anode can is joined to the cathode by crimping thecathode around the indented anode portion, which would also require thedrawn, beaded anode can to be supported by its body during the cathodecrimping. The structure's ability to withstand crimp force would belimited. The present inventors have determined that, in some instances,the crimp force required to crimp the anode can and achieve the properseal at the grommet is greater than the internal retention ledges withinthe can are able to withstand and/or results in buckling of the anodecan. The present inventors have also determined that the drawing andstamping processes associated with conventional anode can manufacturingtechniques undesirably limits anode cans to those which have relativelysymmetric, smooth surfaces and relatively short throws.

SUMMARY

A hearing device core in accordance with at least one of the presentinventions includes a battery and an acoustic assembly with a microphonedefining a medial end and a lateral end and a receiver defining a medialend and a lateral end. The microphone and receiver may be positionedsuch that the lateral end of the receiver substantially abuts the medialend of the microphone, and the battery and acoustic assembly may bearranged such that one of the battery and acoustic assembly is superiorto the other of the battery and acoustic assembly. The presentinventions also include hearing devices that comprise such a hearingdevice core in combination with a seal apparatus on the core.

A hearing device core in accordance with at least one of the presentinventions includes encapsulant as well as a microphone, a receiver andcircuitry located within the encapsulant, and a battery. The encapsulantand at least a portion of the battery defines the exterior surface ofthe hearing device core between the medial and lateral ends of thehearing device core. The present inventions also include hearing devicesthat comprise such a hearing device core in combination with a sealapparatus on the core.

A hearing device core in accordance with at least one of the presentinventions includes encapsulant as well as a microphone, a receiver,circuitry and a battery located within the encapsulant. The encapsulantdefines the exterior surface of the hearing device core between themedial and lateral ends of the hearing device core. The presentinventions also include hearing devices that comprise such a hearingdevice core in combination with a seal apparatus on the core.

A hearing device core in accordance with at least one of the presentinventions includes a microphone, a receiver, circuitry, and a battery,and defines a medial-lateral axis length of about 10-12 mm, a minor axislength of 3.75 mm or less, and a major axis dimension of 6.35 mm orless. The present inventions also include hearing devices that comprisesuch a hearing device core in combination with a seal apparatus on thecore.

A hearing device in accordance with at least one of the presentinventions includes a hearing device core having an acoustic assembly,with a microphone and a receiver with a sound port, and a battery, and aflexible seal apparatus on the hearing device core. The size, shape andconfiguration of the hearing device core, and the flexibility of theseal, are such that the hearing device is positionable within the earcanal bony region with the entire microphone medial of thebony-cartilaginous junction and the receiver sound port eithercommunicating directly with an air volume between the hearing device andthe tympanic membrane or communicating with the air volume through ashort sound tube.

A hearing device core in accordance with at least one of the presentinventions includes a battery, an acoustic assembly with a microphoneand a receiver, a magnetically actuated switch associated with theacoustic assembly, a magnetic shield positioned between the battery andthe magnetically actuated switch. The present inventions also includehearing devices that comprise such a hearing device core in combinationwith a seal apparatus on the core.

A hearing device core in accordance with at least one of the presentinventions includes a microphone, a receiver, circuitry, and a battery,and defies a medial-lateral axis dimension (D_(ML)), a superior-inferiordimension (D_(SI)), and an anterior-posterior dimension (D_(AP)), whereD_(AP)/D_(ML)≦0.38 and D_(SI)/D_(ML)≦0.64 when D_(ML)=10-12 mm. Thepresent inventions also include hearing devices that comprise such ahearing device core in combination with a seal apparatus on the core.

A battery can in accordance with at least one of the present inventionsincludes a cathode portion and an anode portion with an inwardlycontoured region that defines an external retention ledge.

A battery in accordance with at least one of the present inventionsincludes a battery can anode portion including an inwardly contouredregion that defines an external retention ledge, anode material withinthe battery can anode portion, a battery can cathode portion, and acathode assembly within the battery can cathode portion.

A method of assembling a battery in accordance with at least one of thepresent inventions includes the steps of supporting a non-crimped anodecan, with an anode portion, a cathode portion and an external retentionledge, by positioning a support under the external retention ledge, andcrimping the cathode portion.

A method of making a battery can in accordance with at least one of thepresent inventions includes the step of coating a sacrificial mandrel inthe shape of the battery can interior with battery can material.

A battery can in accordance with at least one of the present inventionsincludes a cathode portion defining a first cross-sectional area, ananode portion defining a second cross-sectional area, and a neck portiondefining a third cross-sectional area that is less than the first andsecond cross-sectional areas, and which defines a longitudinallyextending external gap, at the intersection between the cathode portionand the anode portion.

The above described and many other features of the present inventionswill become apparent as the inventions become better understood byreference to the following detailed description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed descriptions of the exemplary embodiments will be made withreference to the accompanying drawings.

FIG. 1 is a section view showing the anatomical features of the ear andear canal.

FIG. 2 is a perspective view of an exemplary hearing device.

FIG. 3 is another perspective view of the hearing device illustrated inFIG. 2.

FIG. 4 is an exploded perspective view of the hearing device illustratedin FIG. 2.

FIG. 5 is an exploded perspective view of a portion of the hearingdevice illustrated in FIG. 2.

FIG. 5A is a perspective view of an exemplary battery.

FIG. 6 is a side view of a portion of the hearing device illustrated inFIG. 2.

FIG. 7 is a medial end view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 8 is a partial section view showing the hearing device illustratedin FIG. 2 within the ear canal.

FIG. 8A is an end view showing the hearing device illustrated in FIG. 2within the ear canal.

FIG. 9 is a perspective view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 10 is an exploded perspective view of a portion of the hearingdevice illustrated in FIG. 2.

FIG. 10A is side view of a portion of an alternative hearing devicecore.

FIG. 11 is a plan view of a portion of the hearing device illustrated inFIG. 2.

FIG. 12 is a plan view of a portion of the hearing device illustrated inFIG. 2.

FIG. 13 is an end view of a portion of the hearing device illustrated inFIG. 2.

FIG. 14 is an end view of a portion of the hearing device illustrated inFIG. 2.

FIG. 15 is a perspective view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 16 is a simplified section view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 17 is a simplified section view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 17A is a simplified section view of a portion of another exemplaryhearing device.

FIG. 18 is an end view of a portion of the hearing device illustrated inFIG. 2.

FIG. 19 is an exploded perspective view of a portion of the hearingdevice illustrated in FIG. 2.

FIG. 20 is a perspective view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 21 is a perspective view of the hearing device illustrated in FIG.2.

FIG. 22 is a perspective view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 23 is a perspective view of a portion of the hearing deviceillustrated in FIG. 2.

FIG. 24 is a perspective view of an exemplary battery.

FIG. 25 is an exploded perspective view of the battery illustrated inFIG. 24.

FIG. 26 is a section view of a portion of the battery illustrated inFIG. 24.

FIG. 27 is an elevation view of an exemplary sacrificial mandrel.

FIGS. 28 and 29 are elevation and top views of an exemplary partiallycompleted anode can formed over the sacrificial mandrel illustrated inFIG. 27.

FIG. 30 is a top view of the partially completed anode can illustratedin FIGS. 28 and 29 can with the sacrificial mandrel removed.

FIG. 31 is an exploded perspective view of an exemplary partiallycompleted battery.

FIG. 32 is diagrammatic view of a crimp apparatus and the partiallycompleted battery illustrated in FIG. 31.

FIG. 33 is a plan view of an exemplary crimp nest.

FIG. 34 is a section view of the partially completed battery illustratedin FIG. 31 in the crimp nest illustrated in FIG. 33.

FIG. 35 is a diagram showing the forces associated with a crimpingprocess.

FIG. 36 is a flow chart showing an exemplary battery manufacturingprocess.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions. Referring to FIG.1, it should also be noted that as used herein, the term “lateral”refers to the direction and parts of hearing devices which face awayfrom the tympanic membrane, the term “medial” refers to the directionand parts of hearing devices which face toward tympanic membrane, theterm “superior” refers to the direction and parts of hearing deviceswhich face the top of the head, the term “inferior” refers to thedirection and parts of hearing devices which face the feet, the term“anterior” refers to the direction and parts of hearing devices whichface the front of the body, and the “posterior” refers to the directionand parts of hearing devices which face the rear of the body.

As illustrated in FIGS. 2-4, an exemplary hearing device 50 includes acore 60 and a seal apparatus 70. A contamination guard 80 may be mountedon the lateral end of the core 60. A handle 90, which may be used toremove the hearing device 50 from the ear canal, may also be provided insome implementations. Generally speaking, the core 60 includes thebattery and acoustic components, the seal apparatus 70 is a compliantdevice that secures the core in the bony region of the ear canal andprovides acoustic attenuation to mitigate occurrence of feedback, andthe contamination guard 80 protects the core from contaminants such asdebris, cerumen, condensed moisture, and oil. The core 60 is discussedin greater detail below with reference to FIGS. 5-18, the seal apparatus70 is discussed in greater detail below with reference to FIGS. 21-23,and the contamination guard 80 is discussed in greater detail below withreference to FIGS. 19-20.

With respect to the core 60, and referring first to FIGS. 5 and 5A, thecore in the exemplary implementation includes an acoustic assembly 100,a battery 200 and encapsulant 300 that encases some or all of theacoustic assembly and battery. The exemplary acoustic assembly 100 has amicrophone 102, a receiver 104 and a flexible circuit 106 with anintegrated circuit or amplifier 108 and other discrete components 110(e.g., capacitors) carried on a flexible substrate 112. The exemplarybattery 200, which is discussed greater detail below with reference toFIGS. 24-36, has an anode can 202 (or “battery can”) that holds theanode material and cathode assembly. In particular, the anode can 202includes an anode portion 202 a for anode material 204 and a cathodeportion 202 b for a cathode assembly 208. The exemplary anode can 202 isalso provided with an inwardly contoured region 202 c (or “neck”) thatdefines an external retention ledge 202 d, i.e., a retention ledge thatis accessible from the exterior of the anode can, at the anode/cathodejunction. The cathode portion 202 b includes a crimped region 206, as isdiscussed below with reference to FIG. 26. The inwardly contoured region202 c and retention ledge 202 d are associated with the battery assemblyprocess, which is discussed below with reference to FIGS. 32-36. To thatend, the inwardly contoured region 202 c defines a longitudinallyextending gap that is sufficiently sized to receive crimp tooling. Theinwardly contoured region 202 c also creates an anchor region for theencapsulant 300 and the external retention ledge 202 d serves as aconnection point for the handle 90 which, in the illustrated embodiment,consists of a pair of flexible cords 92.

The acoustic assembly 100 may be mounted to the battery 200 and, in theillustrated embodiment, the anode can 202 is provided with an acousticassembly support surface 210 with a shape that corresponds to the shapeof the adjacent portion of the acoustic assembly 100 (here, the receiver104). The support surface 210 may in some instances, including theillustrated embodiment, be a relatively flat, recessed area definedbetween side protrusions 212 and a lateral end protrusion 214. Theprotrusions 212 and 214 align the acoustic assembly 100 relative to thebattery and also shift some of the battery volume to a morevolumetrically efficient location. In other implementations, theprotrusions 212 and 214 may be omitted. The battery 200 is connected tothe flexible circuit 106 by way of anode and cathode wires 216 and 218.The battery may, in other implementations, be connected to a similarflexible circuit via tabs (not shown) of the flexible circuit thatattach to the battery.

The exemplary anode can 202 also has a shape that somewhat correspondsto a truncated oval (or D-shape) in cross-section, which contributes tothe overall shape of the core 60. To that end, and referring to FIG. 17,the anode portion 202 a has curved surface 211 opposite the planarsupport surface 210. Similarly, and referring to FIG. 16, the cathodeportion 202 b has a planar surface 213 and a curved surface 215 oppositethe planar surface. The anode can 202 may also taper at the free end(i.e., the left end in FIGS. 5 and 5A).

It should be noted here that the spatial relationships of components ofthe acoustic assembly 100 to one another, and the spatial relationshipof the acoustic assembly to the battery 200 is as follows in theillustrated embodiment. The microphone 102 and the receiver 104 eachextend along the long axis of the core 60, i.e. in the “medial-lateral”direction, with the lateral end of the receiver being closely adjacentto the medial end of the of the microphone. Put another way, themicrophone 102 and the receiver 104 are arranged in in-line fashion inthe medial-lateral direction, close to one another (e.g., about 0.1 to0.5 mm between the two) with the medial end of the receiver at thesuperior medial end of the hearing device and the lateral end of themicrophone at the lateral end of the hearing device core 60. Thecontamination guard 80 may, if present, extend laterally of the core 60.Such an arrangement results in a thinner core, as compared to hearingdevices where the receiver and microphone are arranged side by side. Thepresent core 60 also does not have, and does not need, a sound tube thatextends medially from the receiver, as is found in some conventionalhearing devices, such as the hearing device disclosed in Shennib. Thedirect drive of the air cavity between the receiver and tympanicmembrane by a short spout or port provides for higher fidelity soundtransmission than a sound tube, which can introduce significantdistortion. The flexible circuit 106 may be draped over one or both ofthe microphone 102 and receiver 104 and, in the illustrated embodiment,the flexible circuit is draped over the receiver with a thin portionlocated between the microphone and receiver. Such an arrangement reduceslength of the hearing device core 60 without substantially increasingits girth, i.e. the dimensions in the anterior-posterior andsuperior-inferior directions that are perpendicular to themedial-lateral direction.

With respect to the spatial relationship of the acoustic assembly 100and battery 200, the acoustic assembly and battery are mounted one ontop of the other, i.e. one is superior to the other and acoustic theassembly and battery abut one another. The longitudinal axes of theacoustic assembly 100 and battery 200 are also parallel to one another.The battery 200 is relatively long, i.e., is essentially coextensivewith the acoustic assembly 100 from the medial end of the core 60 to thelateral end of the core, which allows the girth of the battery tominimized without sacrificing battery volume and capacity. Also,referring to FIG. 8, a contour is provided in the illustrated embodimentthat matches (or at least substantially matches) the typical angle ofthe tympanic membrane 14 in the superior-inferior direction, such thatthe lateral most tip of the battery 200 extends more laterally than thelateral most tip of the receiver (note the location of the encapsulantsound aperture 302, which is discussed below). As such, when combined,the acoustic assembly 100 and battery 200 facilitate the construction ofa rigid core that is relatively tall and thin, which the presentinventors have determined is optimal for the ear canal bony portion. Thecross-sectional aspect ratio in planes perpendicular to themedial-lateral axis (i.e., the longitudinal axis) along the length ofthe core 60 is relatively high, i.e. at least about 1.6.

The encapsulant 300 in the illustrated embodiment encases the acousticassembly 100, but for the locations where sound enters the microphone102 and exits the receiver 104 and portions of acoustic assembly thatare secured directly to the battery 200. The encapsulant 300 alsoencases the cathode portion 202 b of the anode can 202, but for thelateral end where air enters, and contoured region 202 c of the anodeportion 202 a. In other embodiments, e.g., the embodiment discussedbelow with reference to FIG. 17A, a thin layer of encapsulant may alsoencase the anode portion 202 a of the anode can 202. Thus, the exteriorsurface of the encapsulant 300 and, in at least some instances, theexterior surface of a portion of the battery 200 defines the exterior ofthe core 60. There is no housing into which the acoustic assembly 100and battery 200 are inserted and, as used herein, the term “encapsulant”does not represent a separate housing into which the acoustic assembly100 and battery 200 are inserted. The acoustic assembly 100 is insteadprotected from contamination and physical force (e.g., during handling)by the encapsulant 300 and the battery 200. In contrast to theillustrated embodiment, essentially all of the combined volume of theacoustic assembly 100 and battery 200 would be located within a housingif a housing was present, and the thickness of the housing walls wouldtherefore add to the length and girth of the core. As such, the use ofencapsulant 300 in place of a housing results in a core with a smallerlength and girth than would be the case if a separate housing wasemployed. Also, as is the case with the anode can 202, the encapsulant300 may have a smooth, rounded outer surface. This may be accomplishedby simply employing an encapsulant mold with such a surface. In summary,due to the configuration of the core 60 (e.g., the relative locations ofthe components of the acoustic assembly 100 and the battery 200, as wellas and the use of encapsulant 300 in place of a housing), the core is aclosely packed unitary structure that can be manufactured in an ovalshape, or other shapes (e.g., elliptical, tear drop, egg) that arewell-suited for the bony region of ear canal, within the dimensions andratios described below. Other benefits associated with the use ofencapsulant include ease of manufacture, as it is not necessary to builda housing (which is a very small device) and position various structurestherein, acoustic isolation of microphone and receiver, and superiorcontamination resistance.

The present inventors have determined that, for a hearing device whichincludes a rigid core and a compliant seal apparatus (e.g., exemplaryhearing device 50), dimensions other than medial-lateral length andcertain ratios are of paramount importance if it is desirable for thehearing device to fit into a large percentage of the intended userpopulation. To that end, and referring to FIGS. 6 and 7, the exemplarycore 60 is generally oval-shaped in cross-section (i.e., oval-shaped inthe girth plane), which corresponds to the superimposed projection ofthe cross-sectional shapes of the ear canal to the bony portion andpresents smooth rounded surfaces to the ear canal. The exemplary core 60has a dimension along the medial-lateral axis (D_(ML)), a dimensionalong the anterior-posterior (or minor) axis (D_(AP)), and a dimensionalong the superior-inferior (or major) axis (D_(SI)). With respect tosize, the present inventors have determined that the core should haveanterior-posterior dimension of 3.75 mm or less (D_(AP)≦3.75 mm), and asuperior-inferior dimension of 6.35 mm or less (D_(SI)≦6.35 mm). Thesedimensions are chosen to fit approximately 75% of the adult population,with smaller dimensions needed to fit smaller ear canals. Put anotherway, in those instances where the medial-lateral dimension is about 12mm (D_(ML)≈12 mm), the ratio D_(AP)/D_(ML)≦0.31 and the ratioD_(SI)/D_(ML)≦0.53. The medial-lateral dimension may range from about10-12 mm, with the other dimensions remaining the same, and the ratioswill vary accordingly. Thus, in those instances where the medial-lateraldimension is about 10 mm (D_(ML)≈10 mm), the ratio D_(AP)/D_(ML)≦0.38and the ratio D_(SI)/D_(ML)≦0.64. The present inventors have determinedthat, when a core with such dimensions and ratios is employed inconjunction with a seal apparatus (e.g., the core 60 with seal apparatus70), the resulting hearing device will have an adult geometrical fitrate of approximately 75%. In other words, for approximately 75% of thepopulation, the hearing device core and seals will fit entirely withinthe ear canal bony portion and the maximum pressure on the ear canalbony portion imparted by the hearing device will be less than the venouscapillary return pressure of the epithelial layer of the canal.

FIGS. 8 and 8A show the exemplary hearing device 50, sized and shaped inthe manner described in the preceding paragraph, positioned within theear canal bony portion 18 such that the core 60 is entirely within thebony portion and the seal apparatus 70 is compressed against the bonyportion. The core 60 is also entirely past the second bend of the earcanal and the bony-cartilaginous junction 20. The encapsulant soundaperture 302 (discussed below), which is located at the medial end ofthe core 60 and at the receiver sound port, faces and is in closeproximity to the tympanic membrane 14 (i.e., about 4 mm from the umbo ofthe tympanic membrane). The benefits of such placement are discussed inthe Background section above. For example, high fidelity sound isachieved because the receiver is in direct acoustic contact with the aircavity AC (FIG. 8) between the tympanic membrane 14 and the medialsurface of the seal apparatus 70. The lateral portion of thecontamination guard 80, which is a flexible structure as discussedbelow, may be entirely within the ear canal bony region 18 or partiallywithin both the bony region and the cartilaginous region 16. Concerningthe 75% fit rate, the present inventors have determined that, for 75% ofthe adult population, the ear canal bony region 18 has a minimumdimension in the superior-inferior direction of at least 4.2 mm and aminimum dimension in the anterior-posterior direction of at least 6.8mm.

It should be noted here that the present cores are not limited to ovalshapes that are, for the most part, substantially constant in size inthe anterior-posterior dimension and the superior-inferior dimension.For example, other suitable cross-sectional shapes include elliptical,tear drop, and egg shapes. Alternatively, or in addition, the core sizemay taper down to a smaller size, in the anterior-posterior dimensionand/or the superior-inferior dimension, from larger sizes at the lateralend to smaller sizes at the medial end, or may vary in size in someother constant or non-constant fashion at least somewhere between themedial and lateral ends.

Turning to FIGS. 9 and 10, and as noted above, the exemplary acousticassembly 100 has a microphone 102, a receiver 104 and a flexible circuit106 with an integrated circuit or amplifier 108 and other discreetcomponents 110 on a flexible substrate 112. The microphone 102 may havea housing 114, with a sound port 116 at one end and a closed end wall118 at the other, a diaphragm 120 within the housing, and a plurality ofelectrical contacts 122 on the end wall 118 that may be connected to theflexible circuit 106 in the manner described below. A suitablemicrophone for use in the exemplary embodiment may be, but is notlimited to, a 6000 series microphone from Sonion. Additionally, althoughthe exemplary microphone housing 114 is cylindrical in shape, othershapes may be employed. The receiver 104 may have a housing 124, with aplurality of elongate side walls 126, end walls 128 and 130, a soundport 132 that protrudes from the housing, a diaphragm 134, and aplurality of electrical contacts 136 (see also FIG. 14) that may beconnected to the flexible circuit 106 in the manner described below. Asuitable receiver for use in the exemplary embodiment may be, but is notlimited to, an FK series receivers from Knowles Electronics. Theexemplary receiver housing 124 is rectangular in shape and the sidewalls 126 are planar in shape. The battery support surface 210 is,therefore, also planar. Other embodiments may employ receivers withother housing shapes and, in at least some instances, the batterysupport surface will have a corresponding shape.

In the illustrated implementation, the superior portion of the medialend of the receiver sound port 132 extends through the sound aperture302, thereby obviating the need for a sound tube. In otherimplementations, e.g. an implantation where the receiver sound port doesnot protrude from the housing, there may be a short sound tube thatextends through, or is simply defined by, the encapsulant. As usedherein, a “short sound tube” is a sound tube that is less than 2 mm inlength. Due to this minimal length, the short sound tube will notadversely effect acoustic transmission in the manner that longer soundtubes may. One example of core that includes a short sound tube isgenerally represented by reference numeral 60′ in FIG. 10A. Here, thesound port of the receiver 104′ is simply an opening in the receiverhousing, and a short sound tube 105 extends to the medial end of theencapsulant 300. The short sound tube may simply be a passage throughthe encapsulant, or may be a short tube that extends through theencapsulant.

With respect to the exemplary flexible circuit 106, and referring alsoto FIGS. 11-14, the flexible substrate 112 includes a main portion 138and a plurality of individually bendable tabs 140-144 that extend fromthe lateral end of the main portion. The flexible substrate main portion138 may be configured to partially or completely cover one or more ofthe side walls 126 of the receiver housing 122 and, in the illustratedembodiment, the flexible substrate main portion covers substantially all(i.e., about 90%) of the surface area of three of the side walls. Theother side wall 126 abuts the battery 200. As a result, the main portion130 is substantially U-shaped. The main portion 130, which also carriesthe integrated circuit 108 and the majority of the other discreetcomponents 110, may be secured to the receiver 104 with an adhesive.Suitable flexible substrate materials include, but are not limited to,polyimide and liquid crystal polymer (LCP). The tabs 140 and 142 carrythe contacts 146 and 148 (FIGS. 11 and 12) that may be soldered orotherwise connected to the contacts 122 and 136 on the microphone 102and the receiver 104. The exemplary contacts 146 and 148 extendcompletely through the flexible substrate 112. The tab 144 carries aswitch 150 that is closed or opened (depending upon the type of switch)to control one or more aspects of the operation of the core 60 (e.g.,volume setting). The switch 150 is located at the lateral end of thecore 60.

In the illustrated embodiment, the switch 150 is a magnetically actuatedswitch. The user simply places a magnet close proximity to the core 60to actuate the switch 150. One example of such a switch is a reedswitch. A magnetic shield 152 (FIG. 16) may be positioned between themagnetically actuated switch 150 and the battery 200 as is discussed ingreater detail below. Other types of user actuated switches may also beemployed in place of, or in conjunction with, the magnetically actuatedswitch. Such switches include, but are not limited to, light-activatedswitches (e.g., visible or infrared light-activated) and RF-activatedswitches.

After the microphone 102 and receiver 104 have been connected to theflexible circuit 106 in the manner described above, the microphone,receiver and flexible circuit may be positioned in the orientationillustrated in FIG. 9 and secured to one another with an adhesive 154 tocomplete the acoustic assembly 100. The adhesive 154 encapsulates therelatively small region between the microphone 102 and receiver 104 inwhich the flexible circuit tabs 140 and 142 are located and directlybonds the microphone to the receiver. In some instances, the adhesive154 may be an adhesive with acoustic damping properties. Alternatively,or in addition to the use of adhesive with acoustic damping properties,a layer of acoustic damping material may be positioned between themicrophone 102 and receiver 104 along with the adhesive 154.

So configured, the acoustic assembly 100 is a unitary structure that maybe mounted onto the battery 200 and, in the illustrated embodiment, themedial ends of the acoustic assembly and battery are at leastsubstantially aligned and the lateral ends of the acoustic assembly andbattery are at least substantially aligned. There may be a slightdifference in medial-most end points (note FIG. 15) to accommodate thecant (i.e., the slant) of the tympanic membrane. For example, themedial-most end points of the acoustic assembly 100 and battery 200might be offset from one another by about 0.5 to 1.5 mm. The result, asshown in FIGS. 6 and 8, is the ability to form a canted lateral outersurface CS which slants at an angle that may be the same as, or at leastsubstantially similar to, that of the tympanic membrane 14.Additionally, although the medial end of the acoustic assembly 100 isslightly lateral of the medial end of the battery 200 in the illustratedembodiment, this may be reversed in those instances where the hearingdevice is intended to be oriented differently within the bony region.The medial and/or lateral ends of the acoustic assembly 100 and battery200 may also be even with one another (i.e., aligned within a toleranceof 0.1 mm).

Referring to FIGS. 15 and 17, the acoustic assembly 100 may be securedto the battery 200 with, for example, a layer of adhesive 156 that islocated between the receiver 104 and the support surface 210. After theacoustic assembly 100 has been secured to the battery 200, the anode andcathode wires 216 and 218 may be connected to the flexible circuit 106with, for example, solder to complete a sub-assembly 55. Alternatively,flex tabs (not shown) could connect to the battery.

As illustrated for example in FIG. 16, the magnetic shield 152, which ispositioned between the magnetically actuated switch 150 and the battery200, is secured to the magnetically actuated switch with adhesive 158.The magnetic shield 152 protects the switch 150 from the residualmagnetization of the anode can 202. The magnetic shield 152 may be athin foil formed from nickel alloys, or may be any other suitablestructure with appropriate high magnetic permeability or paramagneticproperties. The magnetic shield 152 should be at least coextensive withthe portion of the magnetically actuated portion of the switch 150 thatfaces the battery 200. In the illustrated implementation, the magneticshield 152 extends beyond the switch 150 in the anterior and posteriordirections by 0.25 mm or more, extends medially past the switch by 0.1mm or more, and begins 0.2 mm to 0.4 mm medial from the lateral end ofthe switch. The shield 152 is, by virtue of its location at the lateral,crimped end of the battery 60, located in the region of maximum residualmagnetic field strength that results from normal operation.

The encapsulant 300 may then be added to the sub-assembly 55, whichconsists of the acoustic assembly 100 and battery 200, to form the core60. Although the present inventions are not limited to any particularencapsulation process, the encapsulant 300 may be added to thesubassembly through an injection molding process. Briefly, a cylindricalrod (not shown) may be placed into the receiver sound port 132 and thesub-assembly 55 then inserted into a mold (not shown). The shape of theinner surface of the mold will correspond to the shape of the outersurface of the encapsulant 300. Additionally, those portions of thebattery 200 that will not be covered by the encapsulant 300 will be incontact with the inner surface of the mold. The encapsulant 300 in theexemplary implementation will extend from the medial ends of theassociated portions of the acoustic assembly 100 and battery 200, i.e.,the medial end of the receiver 104 and the medial end of the inwardlycontoured region 202 c of the anode can 202, to a point adjacent to butnot over the lateral ends of the acoustic assembly and battery, i.e., toa point up to, but not over, the lateral end surfaces of the microphone102 and the cathode portion 202 b of the anode can 202, so that air andsound may enter the microphone 102 and battery 200.

With respect to the material for the encapsulant 300, suitableencapsulating materials include, but are not limited to, epoxies andurethanes, and are preferably medical grade. After the epoxy or otherencapsulating material hardens, the now encapsulated sub-assembly 55 maybe removed from the mold. The epoxy may, for example, be hardened by UVcuring. The tube may be removed from the receiver sound port 132, whichreveals a sound aperture 302 that is aligned with the receiver soundport 132 (FIGS. 4 and 5), to complete the core 60.

As illustrated in FIGS. 16 and 17, the exemplary encapsulant 300 has anouter surface 304 and an inner volume of encapsulating material 306 thatoccupies the spaces between the components and, in some areas, the spacebetween the components and the outer surface of the encapsulant. Theencapsulant 300 also has a lateral end 308 (FIG. 19) that is slightlymedial (e.g. about 0.3 mm) of the lateral end of the microphone 102 andanode can cathode portion 202 b so that the microphone port 116 andcathode air port 234 (FIG. 18, discussed below) are not occluded. Forexample, and referring to FIG. 16, the encapsulant 300 surrounds aportion of the acoustic assembly 100 (e.g., the microphone 102) and aportion of the battery 200 (e.g., the anode can cathode portion 202 b).Put another way, the encapsulant outer surface 304 defines the outersurface of the core 60 in the lateral region of the core, and themicrophone 102 and the anode can cathode portion 202 b are locatedinward of the encapsulant outer surface 304 in this region. Turning toFIG. 17, in those regions where the anode can 202 defines a portion ofthe outer surface of the core 60, the encapsulant 300 merely surrounds aportion of the acoustic assembly 100 (e.g., the receiver 104 and flexcircuit 106). Put another way, the encapsulant outer surface 304 and theanode can surface 222 each define a portion of the outer surface of thecore 60 in the medial region of the core.

In other implementations, the entire acoustic assembly 100 and entirebattery 200, but for the receiver sound port 132 and the lateral endsurfaces of the microphone 102 and cathode assembly 208, may be encasedin encapsulating material. Thus, as illustrated in FIG. 17A, encapsulant300′ will also extend over anode can outer surface 222 in the anodeportion 202 a of the anode can 202.

As noted above, a contamination guard 80, which protects the core 60from contaminants such as debris, moisture, and oil, may be mounted onthe lateral end of the core in the exemplary embodiment. Suchcontaminants may be occasionally present despite the location of thehearing device 50 within the ear canal bony portion 18. A wide varietyof contamination guards may be employed and, in some implementations, anadditional contamination guard may be placed on the medial end of thecore to protect the receiver port. Referring to FIGS. 19-20, theexemplary contamination guard 80, which is held in place by theencapsulant 300, includes a housing 400, a screen 402 and a flexibletube 404.

The exemplary housing 400 has a convex, generally oval wall 406 that issized and shaped for attachment to the encapsulant lateral end 308 (FIG.18). The wall 406 includes a sound port 408 and a pair of slots 410 thatpermit passage of the handle 90. One side of the wall 406 has anindentation 412 for the screen 402 and the other side includes a supportsurface 414 for the flexible tube 404. One or more tabs 416 (e.g., oneon each side of the sound port 408) may be provided to aid the insertionof the hearing device 50 into, and the removal of hearing device from,the ear canal.

The screen 402 in the illustrated embodiment is in the form of a thinmetal or polymer film 418 with a series of perforations 420 and asurface texture or treatment that imparts hydrophobic andoleophobic/oleoresistant properties. The size/spacing of theperforations 420 and material thickness are such that the screen 402 issufficiently transparent to incoming acoustic waves in the audiblefrequency range, yet retains the ability to repel liquid water andcerumen. This prevents liquid water and cerumen from passing through thecontamination guard 80 and clogging the microphone port 116 and batterycathode port 234 (FIG. 18). In one implementation, the perforations 420may have a diameter that ranges from about 50 microns to about 200microns (e.g., about 100 microns) and pitch of about 150 microns, andthe thickness of screen 402 may range from 10-100 microns.

The exemplary flexible tube 404 has an oval wall 422 and a chamferedsurface 424 with an angle corresponding to that of the housing supportsurface 414. The flexible tube 404 blocks thick and/or solid cerumen,and other solid debris, from being deposited on screen 402 and cloggingthe perforations 420. Suitable materials for the flexible tube 404include, but are not limited to, silicone, polyurethane, thermoplasticelastomers and other elastomers. Additionally, as noted above, theflexibility of the tube 404 allows the tube to be positioned partiallyor entirely in the cartilaginous region 16 because it will bend asnecessary upon touching the canal wall.

Additional information concerning the specifics of exemplarycontamination guards may be found in U.S. Patent Pub. No. 2010/0322452,which is incorporated herein by reference.

As illustrated in FIGS. 21-23, and although the present hearing devicesare not limited to any particular seal apparatus, the exemplary sealapparatus 70 includes a lateral seal 500 and a medial seal 500 a(sometimes referred to as “seal retainers”). The seals 500 and 500 a,which support the core 60 within the ear canal bony portion 18 (FIGS. 8and 8A), are configured to substantially conform to the shape of wallsof the ear canal, maintain an acoustical seal between a seal surface andthe ear canal, and retain the hearing device 50 securely within the earcanal. The seal apparatus 70 may also be used to provide a biocompatibletissue contacting layer and a barrier to liquid ingress. The lateral andmedial seals 500 and 500 a are substantially similar, but for minorvariations in shape, and the seals are described with reference tolateral seal 500 in the interest of brevity. Additional informationconcerning the specifics of exemplary seal apparatus may be found inU.S. Pat. No. 7,580,537, which is incorporated herein by reference.

Referring more specifically to FIGS. 22 and 23, the lateral seal 500includes a shell 502 having an opening 504 and a wall 506 defining acavity 508 for holding the hearing device core 60. The opening 504 maybe centrally placed or offset with respect to the shell 502 and isconfigured to fit over the core 60. The shape of the opening 504 may beoval (as shown) or substantially circular or square. In the illustratedembodiment, the inner portion of the wall 506 includes a plurality ofscallops 510 that may be used to impart the desired level of stiffnessand conformability to the wall. The seals 500 and 500 a may be attachedwith adhesive.

With respect to materials, the seal apparatus 70 (e.g., seals 500 and500 a) may be formed from compliant material configured to conform tothe shape of the ear canal. Suitable materials include elastomeric foamshaving compliance properties (and dimensions) configured to conform tothe shape of the intended portion of the ear canal (e.g., the bonyportion) and exert a spring force on the ear canal so as to hold theseal apparatus 70 in place in the ear canal. Combined with the rigidcore 60, the maximum pressure imparted to the ear canal bony portionwill be less than the venous capillary return pressure of the epitheliallayer of the canal. Exemplary foams, both open cell and closed cell,include but are not limited to foams formed from polyurethanes,silicones, polyethylenes, fluorpolymers and copolymers thereof. In atleast some embodiments, all or a portion of the seal apparatus 70 cancomprise a hydrophobic material including a hydrophobic layer or coatingthat, in at least some instances, is also permeable to water vaportransmission. Examples of such materials include, but are not limitedto, silicones and flouro-polymers such as expandedpolytetroflouroethylene (PTFE). The seal apparatus 70 may also be formedfrom, or simply include, hydrophilic foam or a combination ofhydrophilic and hydrophobic materials.

The uncompressed major and minor dimensions of the shell 502 will dependupon the wearer, and may range from about 9.7 to 13.5 mm and 8.1 to 11.1mm. The major and minor dimensions of the opening 504 will be slightlyless than those of the core 60.

In some implementations, longitudinally extending air vents (not shown)may be provided between the outer surface of the core 60 and the innersurface of the portion of the seal apparatus 70 that engages the core.Such air vents are large enough to provide barometric pressure relief(e.g., during insertion and removal of the device), yet small enough toprevent receiver to microphone sound leakage that causes feedback. Anair vent may be formed by placing a small Teflon filament on the outersurface of the core 60 prior to attaching the seal apparatus 70 to thecore, and then removing the filament after the seal apparatus isattached.

Turning to FIGS. 24-26, and as noted above, the exemplary battery 200has an anode can 202 with an anode portion 202 a for anode material 204and a cathode portion 202 b for a cathode assembly 208. A portion of theanode can 202, i.e., the cathode portion 202 b, is crimped over andaround the cathode assembly 208 in general and the cathode base 226(discussed below) in particular, at the crimp 206. The insulatinggrommet 224 is compressed against the cathode base 226 by the crimp 206to create a seal.

The exemplary battery 200 is a metal-air battery, therefore, the anodematerial 204 is a metal. The metal in the illustrated embodiment iszinc. More specifically, the anode material 204 may be an amalgamatedzinc powder with organic and inorganic compounds including binders andcorrosion inhibitors. The anodic material 204 also includes theelectrolyte, typically an aqueous solution of potassium hydroxide (KOH)or sodium hydroxide (NaOH). Other suitable metals include, but are notlimited to, lithium, magnesium, aluminum, iron and calcium as anodematerial for metal-air battery. Other battery chemistries, such aslithium primary, lithium-ion, silver zinc, nickel-metal-hydride, nickelzinc, nickel cadmium, may be used as the power source.

The exemplary cathode assembly 208, which is carried within the cathodeportion 202 b of the anode can 202 and is insulated from the anode canby the electrically insulating grommet 224, includes a cathode base 226and a cathode sub-assembly 228. The exemplary cathode base 226, whichmay be formed from a conductive material such as nickel plated stainlesssteel, is generally cup-shaped and includes a side wall 230, an end wall232 and an air port 234 that extends through the end wall. The base maybe flat in other embodiments. The insulating grommet 224 has a firstportion 236 that is positioned between the cathode portion 202 b of theanode can 202 and the cathode base 226, and a second portion 238 that ispositioned between the cathode portion 202 b and the cathodesub-assembly 228. The grommet second portion 238 presses the cathodesub-assembly 228 into the cup-shaped cathode base 226. The grommet 224also includes an aperture 240, which is aligned with a correspondingaperture 242 in the anode can 202, that exposes the base wall 232 andair port 234 to the atmosphere. The can aperture 242 is adjacent to thecrimped region 206. Suitable electrically non-conductive materials forgrommet 224 include, but are not limited to nylon and other chemicallycompatible thermoplastics and elastomers.

The illustrated cathode sub-assembly 228 broadly represents severallayers of active and passive materials known in the battery art. To thatend, and although the present inventions are not limited to theillustrated embodiment, air (oxygen) reaches the cathode sub-assembly228 by way of the air port 234 and it is passes through adiffusion-limiting layer 244 (the gas-diffusion barrier) which limitswater loss from the battery by evaporation while allowing sufficientoxygen to pass into the battery to support the required current draw ofthe battery. A cathode catalyst 246 facilitates oxygen reduction in thepresence of electrons provided by a metallic mesh with the production ofhydroxyl ions which react with the zinc anode. Cathode catalyst 246 maycontain carbon material. Embedded in the cathode catalyst 246 is acurrent collector (not shown) that may be composed of a nickel mesh. Thecathode current collector is electrically connected to the metal cathodebase 226. A separator or “barrier layer” (not shown) is typicallypresent to prevent zinc particles from reaching the catalyst 246 whileallowing the passage of hydroxyl ions through it. A shim 248 may bepositioned between the diffusion-limiting layer 244 and the cathodecatalyst 246. The shim 248 helps distribute crimp forces, which resultsin a better seal between the diffusion limiting layer 244 and cathodebase 226, and also closes a possible leakage path that extends along theinner surface of the base wall 232 to the air port 234. Additionaldetails concerning cathode sub-assemblies and other aspects of metal-airbatteries may be found in U.S. Pat. No. 6,567,527.

Referring more specifically to FIG. 26, the anode can 202 is defined bya wall 250 that, in some implementations, may be a multi-layer structurethat includes an inner layer 252 and a outer layer 254. The inner layer252 is formed from a material that has strong hydrogen overpotential.For example, the inner layer 252 may be an oxygen-free copper that formsa surface alloy which inhibits oxidation and reducing reactions with thezinc inside the anode can 202. Other suitable metals for the inner layerinclude tin and cadmium. The structural layer 254, which defines themajority of the thickness of the wall 250, provides the structuralsupport for the anode can 202. The structural layer 254 should besufficiently ductile to allow the portions of the anode can 202 to becrimped, as described below. Suitable materials for the structural layerinclude, but are not limited to, nickel, nickel-cobalt, and nickelalloys. The thickness of inner layer 252 and structural layer 254 mayvary depending on the intended application. In the illustratedembodiment, the inner layer 252 is about 25 μm and the structural layer254 is about 100 μm. In some implementations, the structural layer 254is the outer layer. In others, a thin silver or gold layer (or “silverflash” or “gold flash”) 256 may be located on the exterior surface ofthe nickel layer 254. The silver or gold layer 256, e.g., a layer lessthan about 5 μm, inhibits nickel release from the anode can 202 and aidsin presenting a surface that is easier to form electrical connections towith solder than does, for example, nickel.

As alluded to above, the exemplary anode can 202 includes an inwardlycontoured region 202 c that defines an external retention ledge 202 d atthe junction of the anode portion 202 a and the cathode portion 202 b.So positioned, the external retention ledge 202 d defines part of thecathode portion 202 b. The retention ledge 202 d provides the locationat which the anode can 202 is supported during the crimping of thecathode portion 202 b, as is discussed below with reference to FIGS.32-35. The external retention ledge 202 d in the illustrated embodimentis generally planar and extends outwardly, in a direction that isperpendicular to the longitudinal axis of the anode can 202, from thenarrowest portion of the inwardly contoured region 202 c. The externalretention ledge 202 d also encircles the longitudinal axis. In otherimplementations, the external retention ledge 202 d may be +/−30 degreesfrom perpendicular.

Although not limited to any particular dimensions and metals, theoverall length of the exemplary zinc-air battery 200 is about 10 mmlong, with about 8.85 mm of the total length being occupied by the cananode portion 202 a and the inwardly contoured region 202 c, and about1.15 mm of the total length being occupied by the can cathode portion202 b. Other exemplary lengths include those within the range of 10-12mm. The width is about 3.75 mm and the height, from the support surface210 to the opposite surface is about 2.60 mm. So sized, and unlike aconventional button cell, the exemplary zinc-air battery 200 willprovide sufficient capacity (e.g., at least 70 mAh) and sufficiently lowinternal impedance (e.g., less than 250 Ohms) to power a relatively lowpower continuously worn DIC hearing device for periods exceeding onemonth. In at lease some implementations, the cross-sectional area of thecathode portion 202 b will not exceed 7 mm², and the cross-sectionalarea of the inwardly contoured region 202 c will not exceed 2.5 mm² atits narrowest portion. It should also be noted here that the aspectratio of the present battery, i.e., the ratio of the longest dimension(here, from free end of the anode portion 202 a to the crimped end ofthe cathode portion 202 b) to the maximum dimension of the cross-section(here, the width of the cathode portion 202 b or the anode portion 202 aadjacent to the contoured region 202 c) may be at least 2.0 and, in someinstances, may range from 2 to 5, or may range from 2 to 10, dependingon the internal impendence requirements of the battery.

The exemplary battery 200 is a primary (or “unrechargeable”) battery.However, in other implementations, a secondary (or “rechargeable”)battery may be employed. Here, the cathode catalyst 246 may be replacedby the combination of an oxygen reduction reaction catalyst and anoxygen evolution reaction catalyst, or a bifunctional catalyst, tofacilitate the reverse reaction associated with recharging.

One exemplary method of manufacturing the battery 200, or otherbatteries, will be described below with reference to FIGS. 27-36. Theexemplary method involves the use a sacrificial mandrel (or “mandrel”)onto which the anode can is formed. Referring first to FIG. 27, theexemplary mandrel 600 has a shape that corresponds to the interior shape(and, in the illustrated embodiment, the exterior shape) of the anodecan 202 both before and after crimping, but for the region of thecathode portion 202 b that is crimped. In particular, the mandrel 600includes an anode portion 602 a, a cathode portion 602 b, an inwardlycontoured region 602 c, an external retention ledge 602 d, a flatsurface 610, and protrusions 612 and 614. The sacrificial mandrel 600may, for example, be die cast into the shape of the intended anode can.

The sacrificial mandrel 600 is coated with materials that form the anodecan 202. A variety of coating processes (e.g., physical vapordeposition, spraying and plating processes) may be employed. Oneexemplary process is electroforming (or “electroplating”) and, althoughthe methods are described in that context, the present inventions arenot limited thereto. First, the mandrel 600 is electroplated with copperto form the inner layer 252. The inner copper layer 252 is about 25 μmthick in the illustrated embodiment. The copper coated mandrel 600 isthen further electroplated with ductile nickel to form the structurallayer 254. The nickel structural layer 254 is about 100 μm thick in theillustrated embodiment. A silver or gold flash 256, e.g., a silver layerthat is less than 5 μm, may be applied to the nickel layer 254. The topportions (in the illustrated orientation) of the mandrel 600 and theelectroplated metal layers are removed after the plating process iscomplete. The result is a non-crimped anode can 202-nc that is identicalto the anode can 202 but for a non-crimped cathode portion 202 b-nc andthe remainder of the sacrificial mandrel 600 (FIGS. 28-29). Theremainder of the sacrificial mandrel 600 is then removed from thenon-crimped anode can 202-nc (FIG. 30). For example, the mandrel may bechemically etched away. The non-crimped anode can 202-nc is then readyfor the battery assembly process.

There are a number of advantages associated with forming an anode can bycoating material onto a sacrificial mandrel. For example, it isrelatively easy to precisely form battery cans in a variety of shapes,including symmetric, asymmetric and arbitrary shapes, becausedimensionally precise mandrels in such shapes can be formed bytechniques such as precision injection molding and die casting. In thecontext of the exemplary anode can 202, the use of a sacrificial mandrelfacilitates the formation of a reentrant shape including the inwardlycontoured region 202 c and external retention ledge 202 d. In otherimplementations, a bull nose may be formed at the medial end of anodecan that would occupy the void (prior to encapsulation) between thesupport surface 210 and the receiver sound port 132 (note FIG. 15).Other reentrant shapes may be employed as desired to, for example,increase the volumetric efficiency of the anode can and/or to makeportions of the battery can conform to the shapes of associated portionsof the acoustic assembly.

In addition to the benefits of the external retention ledge discussedbelow, as compared to an internal retention ledge, the present processforms the retention ledge with fewer steps and fewer parts. Also, anodecans with longer throws (and larger aspect ratios), as compared to anodecans formed by stamping and drawing processes, can be formed.

The battery 200 may then be assembled as follows. The non-crimped anodecan 202-nc, non-deflected insulating grommet 224-nd, and the otherbattery components are shown in FIG. 31 in their pre-assembled states.First, the non-crimped anode can 202-nc is filled with anode material(e.g., zinc) and electrolyte solution (e.g., NaOH). The non-deflectedinsulating grommet 224-nd may then be placed into the non-crimped anodecan 202-nc, followed by the cathode sub-assembly 228 and cathode base226 (i.e., the cathode assembly 208).

The next step of the exemplary assembly process is the crimping of thenon-crimped anode can 202-nc. As used herein, the term “crimping” refersto any suitable process of joining two parts by mechanically deformingone or both of them to hold the other, and a “crimp” is the region ofdeformed metal resulting from such a process. Referring to FIGS. 32-34,the non-crimped anode can 202-nc (with the other components therein) maybe loaded into a crimp apparatus 700 that includes a crimp nest 702 anda crimp press 704. The crimp nest 702 includes a pair of nest members706 a and 706 b that support the non-crimped anode can during the crimpprocess. Each nest member includes a base 708, a curved recess 710 and acurved support member 712. The curved support members 712 have anindentation 714. The recesses 710, support members 712 and indentations714 are respectively sized and shaped such that, when the nest members706 a and 706 b are brought together, the support members fit into theinwardly contoured region 202 c. The external retention ledge 202 dwill, accordingly, rest on and be supported by the support members 712during the crimping process. Put another way, the cathode portion 202 bof the anode can, but not the anode portion 202 a, will be subjected tocrimping forces during the crimping process. The bottom end of thenon-crimped anode can 202-nc is not vertically supported, i.e., thenon-crimped anode can is hanging from the retention ledge 202 d.

The exemplary crimp press 704 includes a crimp tool 716, which is usedto deform the non-crimped cathode portion 202 b-nc, and a holder 718,which is used to maintain the position of the cathode assembly 208during the crimping process. The crimp tool 716 includes a crimp surface720 that corresponds to the intended shape of the work piece (i.e., theshape of crimped anode can cathode portion 202 b). In some instances, aplurality of crimp tools will be used in series to achieve the crimp 206(FIG. 26). The holder 718 is movable relative to the crimp tool 716, andis biased toward the work piece (e.g., with a spring) with a biasingforce that will hold the cathode assembly 208 during crimping withoutdamaging the cathode assembly. The exemplary crimp press 704 alsoincludes a fixture (not shown) to hold the crimp nest 702, and a drivemechanism (not shown), such as a servo drive, to drive the crimp tool716 into the non-crimped cathode portion 202 b-nc (note the arrow inFIG. 32).

There are a variety of advantages associated with the use of theexternal retention ledge 202 d to support the anode can 202 during thecrimping process. For example, and referring to FIG. 35, the crimp force(F_(C)) imparted to the anode can by the crimp press during the crimpingprocess is opposed solely an opposing force (F_(SM)) imparted by thesupport members 714 located within the inwardly contoured region 202 cand under the external retention ledge 202 d. There is also no force onthe anode can anode portion 202 a (F_(AP)=0). Thus, the amount of crimpforce that can be applied is not limited by the strength of an internalretention ledge or the buckling limit of an elongate anode can, as isthe case with conventional internal retention ledges. The level of forcenecessary to form the seal at the sealing grommet 224 can be appliedwithout regard to failure at a retention ledge or buckling of the can.

In summary, and referring to FIG. 36, the exemplary batterymanufacturing method begins with the application of a metal coating to asacrificial mandrel (Step S01). The sacrificial mandrel is then removed(Step S02), anode material is inserted into the anode portion of theanode can (S03), and a cathode assembly is inserted into cathode portionof the anode can (Step S04). The anode can is then supported in a crimpnest solely by an external retention ledge that is located at thejunction of the anode and cathode portions of the anode can (Step S05).A crimp tool is then driven into the cathode portion of the anode can tocreate a crimp (Step S06).

It should be noted here that the battery manufacturing techniquesdescribed above, including but not limited to the use of a can with anexternal retention ledge and the use of a sacrificial mandrel, are notlimited to metal-air batteries in general or zinc-air batteries ingeneral. Nor are the techniques limited to the manufacture of a batterywith a contoured, unitary electroformed anode can. For example, a twostep processes in which the cathode assembly is first crimped and thenattached to a filled, long and arbitrarily shaped anode can (to maximizevolumetric capacity and conform to the requirements of the associateddevice) by a low temperature process such as the use of conductiveepoxy, low temperature brazing, or electroplating.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. By way of example, but not limitation, theinventions include any combination of the elements from the variousspecies and embodiments disclosed in the specification that are notalready described. The present inventions also includes hearing devicescores, as described above and claimed below, without a seal apparatus.The claims are not limited to any particular dimensions and/ordimensional ratios unless such dimensions and/or dimensional ratios areexplicitly set forth in that claim. It is intended that the scope of thepresent inventions extend to all such modifications and/or additions andthat the scope of the present inventions is limited solely by the claimsset forth below.

1-42. (canceled)
 43. A battery can, comprising: a cathode portion; andan anode portion including an inwardly contoured region that defines anexternal retention ledge.
 44. A battery can as claimed in claim 43,wherein the external retention ledge is part of the cathode portion. 45.A battery can as claimed in claim 44, wherein the cathode portiondefines first and second longitudinal ends; the external retention ledgeis located at the first longitudinal end; and the second longitudinalend is crimped.
 46. A battery can as claimed in claim 43, wherein thebattery can defines a longitudinal axis; and the external retentionledge is substantially perpendicular to the longitudinal axis.
 47. Abattery can as claimed in claim 43, wherein the battery can defines alongitudinal axis; and the battery can is asymmetric about thelongitudinal axis.
 48. A battery can as claimed in claim 47, wherein theanode portion and/or the cathode portion includes a substantially planarsurface and a curved surface opposite the substantially planar surface.49. A battery can as claimed in claim 43, wherein the ratio of thelongest dimension of the battery can to the maximum dimension of thebattery can that is perpendicular to the longest dimension is at least2.0.
 50. A battery, comprising: a battery can anode portion including aninwardly contoured region that defines an external retention ledge;anode material within the battery can anode portion; a battery cancathode portion; and a cathode assembly within the battery can cathodeportion.
 51. A battery as claimed in claim 50, wherein the externalretention ledge is part of the battery can cathode portion.
 52. Abattery as claimed in claim 51, wherein the battery can cathode portiondefines first and second longitudinal ends; the external retention ledgeis located at the first longitudinal end; and the second longitudinalend is crimped.
 53. A battery as claimed in claim 50, wherein thecathode assembly includes a cathode base and a cathode catalyst; aninsulator is located between the cathode base and the battery cancathode portion; and a portion of the battery can cathode portion iscrimped over the cathode base and insulator.
 54. A battery as claimed inclaim 50, wherein the battery can anode portion defines a longitudinalaxis; and the external retention ledge is substantially perpendicular tothe longitudinal axis.
 55. A battery as claimed in claim 50, wherein thebattery can anode portion defines a longitudinal axis; and the batterycan anode portion is asymmetric about the longitudinal axis.
 56. Abattery as claimed in claim 55, wherein the battery can anode portionand/or the battery can cathode portion includes a substantially planarsurface and a curved surface opposite the substantially planar surface.57. A battery as claimed in claim 50, wherein the ratio of the longestdimension of the battery can to the maximum dimension of the battery canthat is perpendicular to the longest dimension is at least 2.0. 58-68.(canceled)
 69. A battery can, comprising: a cathode portion defining afirst cross-sectional area; an anode portion defining a secondcross-sectional area; and a neck portion defining a thirdcross-sectional area that is less than the first and secondcross-sectional areas, and which defines a longitudinally extendingexternal gap, at the intersection between the cathode portion and theanode portion.
 70. A battery can as claimed in claim 69, wherein thecross-sectional area of the cathode portion does not exceed 7 mm2.
 71. Abattery can as claimed in claim 70, wherein the cross-sectional area ofthe neck portion does not exceed 2.5 mm2 at its narrowest part.
 72. Abattery can as claimed in claim 69, wherein the neck portion is part ofthe anode portion.
 73. A battery can as claimed in claim 69, wherein theanode portion includes a plurality of longitudinally spaced regions thatdefine different cross-sectional shapes.
 74. A battery can as claimed inclaim 69, wherein the anode portion includes a plurality oflongitudinally spaced regions that define different cross-sectionalsizes.
 75. A battery can as claimed in claim 69, wherein the anodeportion includes a plurality of longitudinally spaced regions thatdefine different cross-sectional shapes and different cross-sectionalsizes.